Regulatory Affairs Manager

Amsterdam Vast dienstverband

Toegevoegd 12/02/2021

  • Regulatory Affairs Manager BeNeLux
  • Medical Devices

Over onze klant

Our client is an international Hygiene company and sells FMCG products.


  • You will be the Representative in Europe for Medical Devices
  • Lead and coordinate new license and submissions maintenance
  • Lead the Regulatory function within the BeNeLux
  • Ensure the growth and development of the Regulatory Team
  • Manage a complex and diverse set of regulatory/registration requirements
  • You will do all hands-on Regulatory activities as well


Medical education. Honours degree is a plus

At least 3 years of experience within Medical Device Regulation is a must

Regulatory experience in Medical European registration processes and technical file creation and maintenance

Experience in European registration strategies, submitting dossiers, renewals and variations

Understanding of Global product development practice, guidelines, regulations and rules

Experienced with regulatory environment and emerging guidelines

Being hands on is very important

Fluent in Dutch and English, French would be a plus


Salary with bonus component.

Marlous Zijlstra-Wondergem

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